Active Choice in the EHR to Promote Statin Therapy

Cardiovascular Diseases Clinical Trial

Official title:

Using Active Choice in the EHR to Promote Cardiologists to Prescribe Evidence-Based Statin Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03271931
• Other study ID #: 827983
• Status: Completed
• Phase: N/A
• Start date: September 24, 2018
• Est. completion date: June 5, 2019

Study information

• Verified date: July 2019
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Cardiovascular (CV) events are the leading cause of mortality in the United States. Statins have been demonstrated to be an effective tool for reducing CV events and mortality, but statins are often either not prescribed or under-prescribed for patients that meet evidence-based guidelines. In this study, we will evaluate a health system initiative using active and passive choice prompts in the electronic health record to prompt cardiologists to prescribe evidence-based statin therapy. In partnership with the health system, this will be conducted as a randomized, controlled trial to evaluate its effect.

Description:

This study will use a randomized, controlled trial to evaluate a health system initiative. Cardiologists randomly assigned to the control arm will receive no interventions. For cardiologists randomly assigned to the active choice intervention, the electronic health record will be used to prompt cardiologists to initiate or change statin therapy for patients not on evidenced-based guidelines based on the 2013 American College of Cardiology / American Heart Association (ACC/AHA) and the National Lipid Association (NLA) through a "best practice alert" in Epic which appears on the screen and forces a decision before the clinician can move on. For cardiologists randomly assigned to the passive choice intervention, the electronic health record will be used to create a passive alert using the same evidence-based guidelines. The passive alert will not block clinician workflow and instead will be available in the background for the cardiologist to open and then use to make a prescribing decision. The intervention period will be 6 months in duration.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23066
• Est. completion date: June 5, 2019
• Est. primary completion date: June 5, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Have a cardiologist at the University of Pennsylvania Health System

• Meets 2013 ACC/AHA or NLA guidelines for statin prescription

Exclusion Criteria:

• Allergy to statins

• Severe renal insufficiency defined as glomerular filtration rate (GFR) less than 30 mL/min or on dialysis

• Adverse reaction to statins including a) myopathy, b)rhabdomyolysis, c)hepatitis

• Pregnant

• On a PCSK9 Inhibitor medication

Related Conditions & MeSH terms

• Cardiovascular Diseases

Intervention

Behavioral:
• Active choice
EHR alert prompting cardiologists to make an active choice to prescribe a statin or not.
• Passive choice
EHR passive alert to cardiologists about prescribing a statin

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the percent of eligible patients prescribed statin therapy at a dose that meets evidence-based guidelines	Among patients not on guideline-based statin dosages, the percent that are prescribed guideline-based therapy at appropriate dose.	6 Months
Secondary	Change in percentage of eligible patients prescribed a statin, at any dose.	Among patients not on a statin, the percent that are prescribed guideline-based therapy, at any dose.	6 Months